Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide together
with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving temozolomide together with
radiation therapy works in treating patients with low-grade gliomas.

Additional Information

Official title

A Phase II Study of a Temozolomide-Based Chemoradiotherapy Regimen for High-Risk Low-Grade Gliomas

Principal investigator

Barbara J. Fisher, MD

Description

OBJECTIVES:
- Compare the 3-year survival of patients with high-risk low-grade gliomas treated with
temozolomide and radiotherapy followed by temozolomide alone with that of patients
enrolled on European Organization for Research and Treatment of Cancer (EORTC)clinical
trials EORTC-22844 and EORTC-22845.
- Determine the toxicity of this regimen in these patients.
- Determine the association between progression-free survival and O6-methylguanine-DNA
methyltransferase (MGMT) methylation status in patients treated with this regimen.
- Determine the association between survival and MGMT methylation status in patients
treated with this regimen.
- Determine the quality of life (QOL) of patients treated with this regimen.
- Determine the neurocognitive function of patients treated with this regimen.
- Evaluate the feasibility of collecting patient-reported QOL and neurocognitive
assessments over 3 years.
OUTLINE: This is a non-randomized, multicenter study.
Patients receive oral temozolomide once daily on days 1-42 and undergo radiotherapy once
daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning 28 days after completion
of chemoradiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment
with temozolomide repeats every 28 days for up to 12 courses in the absence of disease
progression or unacceptable toxicity.
Quality of life is assessed periodically for up to 36 months.
After completion of study treatment, patients are followed at 4 months, every 6 months for 2
years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 135 patients will be accrued for this study within 44 months.

Trial information was received from ClinicalTrials.gov and was last updated in November 2015.